FDA 510(k)

ACCUSYTE 3D 표지자

K-번호: K180027 · 2018-07-18

결정일2018-07-18

제품 코드IYE

자문 위원회RA

결정Substantially Equivalent

기기 요약

ACCUSYTE 3D Fiducial Marker is the device name listed in this FDA 510(k) record. The listed applicant is Radiation Products, LLC. It received FDA 510(k) clearance on 2018-07-18 under 510(k) number K180027. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ACCUSYTE 3D Fiducial Marker?

ACCUSYTE 3D Fiducial Marker is a medical device that received FDA 510(k) clearance on 2018-07-18. The listed applicant is Radiation Products, LLC. The 510(k) number is K180027.

When did ACCUSYTE 3D Fiducial Marker receive FDA 510(k) clearance?

ACCUSYTE 3D Fiducial Marker received FDA 510(k) clearance on 2018-07-18, under 510(k) number K180027.

Who is the listed applicant for ACCUSYTE 3D Fiducial Marker?

The FDA 510(k) record lists Radiation Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUSYTE 3D Fiducial Marker?

The FDA product code for ACCUSYTE 3D Fiducial Marker is IYE.

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ACCUSYTE 3D 표지자

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: IYE)

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